News & Events

THE NEW AMERICAN DIVISION OF KALMS CONSULTING/

PROVIDING AMERICAN FIRMS FASTER ACCESS TO THE EUROPEAN HEALTH CARE MARKET

Kalms Consulting is pleased to announce that it is opening two new American of ces in the most vi- brant healthcare technology regions of the United States: San Francisco and Minneapolis.

Navigating FDA approval can be a signi cant in- vestment in time and dollars. Executing a dual pathway strategy via the European market can provide a streamlined opportunity that quickly al- lows manufacturers to jumpstart revenue gains, develop a strong health economics story, and ag- gregate additional clinical data needed to success- fully gain approval in the U.S. The European mar- ket is also an attractive target for well-established companies looking to expand beyond their native country. Kalms Consulting enjoys longstanding re- lationships with small, mid-cap and large, US-based medical device, biotech, biopharma and life science clients who continue to bene t from broadening their revenue pathways in Europe. Establishing permanent of ces in the United States to better serve existing and future clients made perfect sense. The Kalms Consulting team is comprised of experienced and highly quali ed experts who deliver affordable, data-driven solutions to clients worldwide. The U.S. division will speci cally focus its efforts on market access, strategic business development, technology assessment and market analysis while working in concert with their European counterparts.

MARCO KALMSFounder & CEO

“It is my pleasure to introduce the American Division of Kalms Consulting. With these of ces we’re giving American rms a better opportunity to access the German and European market.”

KALMS CONSULTING SAN FRANCISCO/

HEALTH CARE IS THE BIGGEST INDUSTRY IN THE BAY AREA

San Francisco is the cultural, commercial, and financial center of Northern California.California has a great history of innovation in life sciences, developing new technologies to solve health problems.

As the birthplace of biotechnology California stands for the innovation in life sciences in particular. Genomic technologies help detect diseases, while new therapies and devices help to treat them. Digital health technologies help prevent diseases and provide patients with better tools to manage their con- ditions.

Life Sciences is a cornerstone of California’s econ- omy and contributes to a healthier society and advances new medical technologies.California’s life sciences community continues to grow, with 3,040 life sciences companies – 192 more than the previous year – producing new technolo- gies and boosting the state’s economy. In 2015, the Golden State’s life sciences industry employed more than 287,000 people. This highly trained and diverse workforce helped develop novel drugs, devices and diagnostics, while also exploring other applications, such as leveraging biotechnology to produce sustainable energy. “Life sciences companies have been incredibly successful. As of September 7, 2016, 1,269 drugs from Californian companies were in the FDA pipeline. In 2015, 264 new devices developed by Californian companies were approved. Academic excellence, forward-thinking public policy and the commitment of thousands of entrepreneurs and business leaders has translated into new ways to address some of the world’s most severe medical conditions: cancer, hepatitis, HIV, rare diseases and many others. These efforts help power our economy and provide health for millions around the world.”1

“Being the center of technological innovation on the West Coast San Francisco is the perfect loca- tion for opening a Kalms Consult- ing of ce. We are going to provide start ups with easier access to the rich European market.”

KALMS CONSULTING MINNEAPOLIS/

A HEALTH AND MEDICAL INDUSTRY HUB WITH TRADITION

Minneapolis is the county seat of Hennepin County, and the larger of the Twin Cities.Minneapolis and Saint Paul anchor the second-larg- est economic center in the Midwest, after Chicago. Minneapolis lies on both banks of the Mississippi River, just north of the river’s con uence with the Minnesota River, and adjoins Saint Paul, the state’s capital. The city is abundantly rich in water, with thirteen lakes, wetlands, the Mississippi River, creeks and waterfalls.

Minneapolis has a great tradition of making an im- pact on the health eld and continues to do that today. It hosts the University of Minnesota, which ranks in the top three research universities in the USA. Medical device research is robust at the University of Minnesota. One of the most innovative health providers in the nation, Mayo Clinic, is just an hour and a half drive to the south in Rochester.

Multiple Fortune 500 companies in the health eld were founded in Minneapolis, and the impression these companies have left via innovations reverberates throughout the world.According to the Minnesota-based Medical Alley Association more than two-thirds of last year’s PMAs out of FDA went to applicants out of Califor- nia and Minnesota.

TIMOTHY ZIAJABusiness Development U.S.

“With Minneapolis’ history of Medical Innovation and achieve- ment the founding of the Minneapolis division of Kalms Consulting will provide existing rms and start ups a gateway to the international stage.”

JIM KAZMIERKOSKIBusiness Development U.S.

“The location of Minneapolis in the midwest region provides easy access to rms in Cleveland, Madison and Milwaukee.”

EVENTS

An expert panel discussion about what challenges healthcare companies will face, but the experts also addressed the rewards that lie in international expansion. What is the best way to set up a com- pany, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there was a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this. Michael Kauch, Associate Partner Strategy & Public Affairs to Kalms explained in his talk the current situation of “Reimbursement and devel- opments in Health Policy in Germany“. The panel discussed key factors for succeeding and investing in the German market as a starting point for further international expansion.

Supported by Kalms Consulting, high level German business delegations have visited our client Intui- tive Surgical in the headquarter in Sunnyvale, Cali- fornia. 60 entrepreneurs, VC companies and supporting agencies were part of the Silicon Valley tour of the German start-up association (Bundesverband Deutsche Startups). Also the German Ministry of Economic Affairs had been represented. Furthermore, a delegation of the Vodafone Enterprise Fo- rum, led by a Vodafone Germany board member, came to see the latest technological developments in robotic assisted surgery. Both groups were im- pressed how Intuitive Surgical has made its way from a start-up to a market leader - and how Intuitive Surgical is constantly improving its technolo- gies for the bene t of surgeons, hospitals and pa- tients.

„Please join us for a panel discussion on how to enter the European market via Germany as a life sciences company. We will discuss key factors for succeeding and investing in the German market as a starting point for further international expansion.

Our experts will discuss what challenges healthcare companies will face, but will also address the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there will be a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this.

After the panel discussion we hope you join us for little bit less of a 'healthy' happy hour with appetizers and drinks. We look forward to seeing you there!“

Kalms & Partner Consulting will participate in the J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco. At this event, investors and executives from all over the world meet with companies presenting their latest innovations and new partnerships are decided.

REIMBURSEMENT OPTIONS IN THEGERMAN HEALTHCARE SYSTEM

DIRECT CONTRACTS AS AN OPPORTUNITY FORINNOVATIVE MEDICAL DEVICES

In outpatient medical care, the direct contract is the counterpart of the collective contract. Collective contracts are agreed on the national level by the associations of physicians and the association of health insurance companies. Collective contracts are binding for doctors and health funds. The direct contract, on the other hand, offers individual agreements of health funds with service providers and producers of medical devices.

This enables contractual partners to flexibly respond to needs that exist in specific types of care or when treating particular illnesses. The areas in which direct contracts can be used have been widened considerably in the past few years. For patients this results in better care from one provider. The implementation of the new law for strengthening the provision in statutory healthcare insurance (Versorgungsstärkungsgesetz) in 2015 created new opportunities for direct contract arrangements.

It also simplified existing forms of contractual arrangements. The new law envisages a systematic continued development of opportunities for direct contracts for all service providers. So far, the types of contracts were regulated by different sections of the health code (Sozialgesetzbuch V). They have now been condensed in a new clause (§ 140a SGB V) as ‘special care provision’.

These contracts can cover matters such as services for early diagnosis, specialized outpatient care, as well as new examination and treatment methods whose applications follow medical good practice.

Content of the new article of law

§ 140a SGB V Special Care Provision

Health funds may enter contracts concerning special care provision for insured persons with service providers shown in Illustration 1.

It enables a cross-sector care concepts or an interdisciplinary approach (integrated care). These are legal prerequisites and not negotiable. It also allows contracts for special medical outpatient care involving approved contracted medical service providers or their associations. Insured persons who want to benefit from the special care of their health fund have to submit their voluntary participation in writing to their health fund. Insured persons can revoke their consent with the health fund within two weeks of submission either in written form or as a written transcript without giving a reason. It needs to be stressed that treatments already rejected by the Joint Government Committee (Gemeinsamer Bundesausschuss) may not be part of the contracts. The contractual parties also have to prove within a certain fixed timeframe (usually four years) that the treatment specified in the contract constitutes an improvement with regard to quality and cost effectiveness for the community.

The number of direct contracts will rise

We are aware of approximately 800 contracts in 2012. In 2014 the Association of Statutory Health Insurance Physicians reported 1,850 direct contracts. This trend points towards a considerable rise in the coming years.

Great opportunities for medical device companies

It is an aim to promote competition for members between health funds as well as competition between service providers. Direct contracts should therefore increase the efficiency and quality of patient treatment and also facilitate innovation. Kalms and Partner have excellent contacts in the German healthcare sector, also in the health funds. We would be pleased to support our customers with initiating contacts with individual health funds to initiative contracts – if the legal prerequisites.

According to the new law healthcare insurance companies may enter contracts with the following entities:

Boards of institutions offering special treatments for insured persons on the basis of Chapter 4 of the law

Statutory nursing care insurers and approved care institutions on the basis of §92b Book 11

Healthcare centres on the basis of §115 Section 2 Sentence 1 Number 1

Pharmaceutical companies

Medical device companies as de ned by the law for medical devices

Associations of Statutory Health Insurance Physicians in order to support members taking part in special care provision

Author | Barbara SengerReimbursement,Market Access & PR

ABOUT

YOUR EXPERTS

ELLEN HOLTMANNProject Management & Reimbursement

Ellen Holtmann is our team member for Quality Management, Quali cation for market access (incl. national and international requirements for the development and manufacture of medical products also in respect to product liability), national and international requirements for clinical assessment and approval of medical products, national and international aspects of the bringing to market and monitoring of products during the product life cycle. Ellen Holtmann holds a University certification being a qualified Manager Regulatory Affairs Medical Devices International.

During her work in the Medical Device Market since 2000 and besides collecting multiple experiences in the field of Customer Service, Customer Relation Management, Office Management, Marketing, Healthcare Compliance, Quality Management , International Sales Management (Austria and Switzerland) and Business Development. Ellen Holtmann is looking back on a working partnership with Marco Kalms for more than 14 years. She is a native speaker in German and fluent in English.

HOLGER SCHAFFRATH, Ph.D.Market Access & Reimbursement

Dr. Holger Schaffrath has 25 years of experience in sales, marketing, operations and General management for entities of primarily US based medical device companies in Central European markets. This has included working for Boston Scientific for 5 years and in aggregate for Medtronic and AVE 13 years, acquired by Medtronic in 2000. In recent years he has focused on managing startups launching vascular intervention and neurostimulation products, and has steered related therapies through the phases of market access and adoption in Germany, including clinical, reimbursement related and commercialization aspects. As a Senior Consultant he provides our clients with a broad portfolio of profound knowledge of the German health care system combined with insider knowledge of the medical device industry and related markets.

Holger received a diploma in information sciences and holds a Ph.D. degree in biomedical engineering. To round his professional skills off he is a certified psychological adviser and management coach.

EVENTS

MEMBER OF PARLIAMENT AT LIVE SURGERY WITH DaVinci

Intuitive Surgical is the leading company in robotic assisted surgery and has developed the DaVinci surgical system. Kalms & Partner Consulting is supporting Intuitive Surgical in the field of Public Affairs. To demonstrate the impact of the technology for high quality surgery, we have initiated a visit by Dr. Georg Kippels, Member of the German federal Parliament, to the St. Antonius Gronau hospital - the leading center for robotic surgery in Europe. Dr. Kippels was able to take part in a 3D live transmission of a minimally invasive prostate surgery - an impressive experience for a policy dialogue on quality medicine.

SHORT NEWS

PROGRESS FOR OUR CLIENT ALLERGAN

Curing severe forms of incontinence - this is the aim of the Botox injection to the overactive bladder. Kalms & Partner Consulting is supporting Allergan, the producer of Botox, in regard to the application of the method to the outpatient sector. One instrument are contracts with major health funds. Allergan and Kalms & Partner Consulting can now report further progress in the efforts to improve access of patients in ambulatory surgeries.

After a DAK contract in the region of Westphalia-Lippe two more contracts have included the Botox injection to the overactive bladder: DAK in Bavaria and AOK in Baden-Württemberg.

This is good news for the patients and for the physicians who nally get a much better reimbursement than before.

SHORT NEWS

Taking place in Düsseldorf November 14th – 17th, MEDICA is the world’s largest event for the medical sector with more than 5,500 exhibitors (including more than 500 U.S. exhibitors) in 19 exhibit halls and expected and 130,000 trade-only visitors from 120 countries.

The CEO program was developed by theU.S. Commercial Service in order to offer US companies a unique opportunity to promote their exports and to meet customers and qualified distributors from all over Europe and the world at affordable cost.

Kalms & Partner Consulting is happy to participate in this event in order to continue our activities in successfully supporting US based companies with their German and European activities.

KALMS & PARTNER CONSULTING EXPERT MEETING ON NEW BENEFIT ASSESSMENT

In July 2016, Kalms & Partner Consulting successfully gave an expert workshop on the New Benefit Assessment (NUB) implemented in the German reimbursement system. It applies to certain methods with medical devices provided an NUB application is submitted by a hospital.

In the workshop, Kalms & Partner consultants explained details of the new law, its implications for the medtech companies and strategy recommendations for our clients. Additionally, participants had the opportunity to discuss the matter with high-level representatives of the Association of German University Hospitals and of the Joint Federal Committee, the most important self-administration body of the German health system.

If you missed the workshop, but are planning an NUB application in 2017, please contact your Kalms & Partner consultant as early as possible, as applications that may be subject to a benefit assessment have to be carefully prepared several months ahead of the deadline.

Michael Kauch, Associate Partner Strategy and Public Affairs at Kalms & Partner Consulting is speaker at the Webinar:“Success in the European Medical Device Market and Medica 2016”, organized by the U.S. Commercial Service.Please klick here for details.